MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
FDA premarket approval P940031/S011 · decided 1998-04-30
Approval details
- PMA number
- P940031
- Supplement
- S011
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MERIDIAN AND DISCOVERY PACEMAKER SYSTEMS
- Applicant
- Boston Scientific
- Date received
- 1997-10-24
- Decision date
- 1998-04-30
- Days to decision
- 188 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the addition of the MERIDIAN(TM) and DISCOVER(TM) Pacemaker Systems to the current VIGOR family of pacemakers. The device, as modified, will be marketed under the trade name MERIDIAN(TM) and DISCOVERY(TM) Pacemaker Systems and is generally indicated for long-term cardiac pacing. Generally accepted indications for long-term cardiac pacing include, but are not limited to, sick sinus syndrome; chronic sinus arrhythmias, including sinus bradycardia, sinus arrest, and sinoatrial (SA) blo
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